Comparison of the SUpera® PERipheral System in the Superficial Femoral Artery

Peripheral Vascular Disease Clinical Trial

— SUPERB  

Official title:

Comparison of the SUpera® PERipheral System to a Performance Goal Derived From Balloon Angioplasty Clinical Trials in the Superficial Femoral Artery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00933270
• Other study ID #: SFA-1 US/EU
• Status: Completed
• Phase: Phase 3
• First received: July 2, 2009
• Last updated: May 7, 2015
• Start date: July 2009
• Est. completion date: July 2014

Study information

• Verified date: May 2015
• Source: IDev Technologies, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a prospective, multicenter, non-randomized, single arm, pivotal trial.

The main objective of this study is to demonstrate the safety and effectiveness of the IDev SUPERA® Nitinol Stent System in treating subjects with obstructive superficial femoral artery (SFA) disease. The primary endpoint will be the primary patency of the SFA evaluated at 12 months. The outcome will be compared to a performance goal based on clinical trials of percutaneous transvenous angioplasty (PTA) alone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 325
• Est. completion date: July 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age greater than or equal to 18 years and of age of legal consent.

2. Women of child bearing potential must have a negative pregnancy test within 7 days prior to the index procedure.

3. Subject has lifestyle limiting claudication or rest pain (Rutherford-Becker scale 2-4) with a resting ankle-brachial index (ABI) less than or equal to 0.9. TBI (toe-brachial index) is performed only unable to assess ABI. TBI must be less than or equal to 0.7.

4. A single superficial femoral artery lesion with greater than 60% stenosis or total occlusion.

5. Stenotic lesion(s) or occluded length within the same vessel (one long or multiple serial lesions) greater than or equal to 40 mm to less than or equal to 140 mm. Reference vessel diameter (RVD) greater than or equal to 4.0 mm and less than or equal to 6.0 mm by visual assessment.

6. All lesions are to be located with the distal point at least 3 cm above the knee joint, defined as the distal end of the femur at the knee joint, and proximal point at least 2 cm below the origin of the profunda artery.

7. Patent infrapopliteal and popliteal artery, i.e., single vessel runoff or better with at least one of three vessels patent (less than 50% stenosis) to the ankle or foot.

8. The target lesion(s) can be successfully crossed with a guide wire and dilated.

9. Poor aortoiliac or common femoral "inflow" (i.e., angiographically defined greater than 50% stenosis of the iliac or common femoral artery) that would be deemed inadequate to support a femoropopliteal bypass graft must be successfully treated prior to treatment of the target lesion. This can be done just prior to treatment of the target lesion. Successful treatment is defined as less than 30% stenosis after either PTA or stenting of the inflow lesion. After treatment of the inflow lesion, the pressure gradient across the target lesion will be obtained and if the pressure gradient is greater than or equal to 20 mmHg, then the subject will be included in the study.

10. A subject with bilateral obstructive SFA disease is eligible for enrollment into the study. If a subject with bilateral disease is enrolled, the target limb will be selected at the Investigator's discretion, who may use the criteria of lesion length, percent stenosis, and/or calcification content. The contra-lateral procedure should not be done until at least 30 days after the index procedure (staged); however, if contralateral treatment is performed prior to treatment of the target lesion, the waiting period will be at least 14 days prior to the index procedure.

11. The subject is eligible for standard surgical repair, if necessary.

12. A subject who requires a coronary intervention should have it performed at least 7 days prior to the treatment of the target lesion.

13. Subject must provide written informed consent.

14. Subject must be willing to comply with the specified follow-up evaluation schedule.

Exclusion Criteria:

1. Thrombophlebitis or deep venous thrombus, within the previous 30 days.

2. Receiving dialysis or immunosuppressant therapy within the previous 30 days.

3. Thrombolysis of the target vessel within 72 hours prior to the index procedure, where complete resolution of the thrombus was not achieved.

4. Stroke within the previous 90 days.

5. Ipsilateral femoral aneurysm or aneurysm in the SFA or popliteal artery.

6. Required stent placement via a popliteal approach.

7. Required stent placement across or within 0.5 cm of the SFA/PFA bifurcation.

8. Procedures which are pre-determined to require stent-in-stent placement to obtain patency, such as in-stent restenosis.

9. Significant vessel tortuosity or other parameters prohibiting access to the lesion or 90° tortuosity which would prevent delivery of the stent device.

10. Required stent placement within 1 cm of a previously deployed stent.

11. Subject required a coronary intervention, and the coronary intervention was done less than 7 days prior to or planned within 30 days after the treatment of the target lesion.

12. Known allergies to any of the following: aspirin and all three of the following:

clopidogrel bisulfate (Plavix®), ticlopidine (Ticlid®), and prasugrel (Effient®); heparin, nitinol (nickel titanium), or contrast agent, that cannot be medically managed.

13. Presence of thrombus prior to crossing the lesion.

14. Known or suspected active infection at the time of the procedure.

15. Presence of an ipsilateral arterial artificial graft.

16. Use of cryoplasty, laser, or atherectomy devices at the time of index procedure.

17. Restenotic lesion that had previously been treated by atherectomy, laser or cryoplasty within 3 months of the index procedure.

18. Subject has tissue loss, defined as Rutherford-Becker classification category 5 or 6.

19. History of neutropenia, coagulopathy, or thrombocytopenia that was unexplained or is considered to be at risk for reoccurrence.

20. Known bleeding or hypercoagulability disorder or significant anemia (Hb < 8.0) that cannot be corrected.

21. Subject has the following laboratory values:

1. platelet count less than 80,000/µL,

2. international normalized ratio (INR) greater than 1.5,

3. serum creatinine level greater than 2.0 mg/dL.

22. Subject requires general anesthesia for the procedure.

23. Subject is pregnant or plans to become pregnant during the study.

24. Subject has a co-morbid illness that may result in a life expectancy of less than 1 year.

25. Subject is participating in an investigational study of a new drug, biologic or device at the time of study screening. NOTE: Subjects who are participating in the long term follow-up phase of a previously investigational and now FDA-approved product are not excluded by this criterion.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Device:
• SUPERA® Nitinol Stent System
Percutaneous Angioplasty of the Superior Femoral Artery with placement of a SUPERA® Stent at time of PTA

Locations

Country	Name	City	State
United States	Alice Heart Center	Alice	Texas
United States	Austin Heart, P.A	Austin	Texas
United States	Cardiovascular Specialist of Texas & North Austin Medical Center	Austin	Texas
United States	Heritage Valley Health System	Beaver	Pennsylvania
United States	North Cascade Cardiology, PLLC	Bellingham	Washington
United States	ACT / CVRI & Cedar Sinai Medical Center	Beverly Hills	California
United States	Willis Knighton Bossier Medical Center	Bossier City	Louisiana
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachussetts General Hospital	Boston	Massachusetts
United States	Bradenton Cardiology Center	Bradenton	Florida
United States	Caritas-St. Elizabeth Medical Center	Brighton	Massachusetts
United States	Deborah Heart	Browns Mills	New Jersey
United States	Cardiology Consultants or Mainline Health System	Bryn Mawr	Pennsylvania
United States	The Lindner Center for Research and Education at The Christ Hospital	Cincinnati	Ohio
United States	University Hospital	Cleveland	Ohio
United States	Ohio Health Research Institute / Riverside Methodist Hospital	Columbus	Ohio
United States	Cardiovascular Research Institute of Dallas	Dallas	Texas
United States	Cardiology Associates of Mobile, Inc.	Fairhope	Alabama
United States	Clarian North / Heart Partners	Fishers	Indiana
United States	Hunterdon Medical Center	Flemington	New Jersey
United States	Plaza Medical Center of Fort Worth	Fort Worth	Texas
United States	Greenville Hospital Systems	Greenville	South Carolina
United States	Hartford Hospital	Hartford	Connecticut
United States	Hattiesburg Clinic, P.A.	Hattiesburg	Mississippi
United States	Terrebonne General Hospital	Houma	Louisiana
United States	Hutchinson Hospital Corporation dba Promise Regional Medical Center	Hutchinson	Kansas
United States	First Coast Cardiovascular Institute	Jacksonville	Florida
United States	Wellmont Holston Valley Medical Center	Kingsport	Tennessee
United States	Cardiovascular Institute of the South	Lafayette	Louisiana
United States	Arkansas Heart Hospital	Little Rock	Arkansas
United States	SJH Cardiology Associates	Liverpool	New York
United States	Mount Sinai Medical Cente	Miami Beach	Florida
United States	Columbia - St. Mary's	Milwaukee	Wisconsin
United States	Cardiovascular Research of Northwest Indiana, LLC	Munster	Indiana
United States	Vanderbilt Medical Center	Nashville	Tennessee
United States	Robert Wood Johnson UMDNJ-RWJMS	New Brunswick	New Jersey
United States	Yale University	New Haven	Connecticut
United States	Lenox Hill Hospital	New York	New York
United States	NYU Medical Center	New York	New York
United States	Montgomery General Hospital	Olney	Maryland
United States	Opelousas General Health System	Opelousas	Louisiana
United States	Banner Good Samaritan Medical Center	Phoenix	Arizona
United States	Maine Medical Center	Portland	Maine
United States	The Miriam Hospital	Providence	Rhode Island
United States	Louisiana Heart Center	Slidell	Louisiana
United States	Tucson Medical Center	Tucson	Arizona
United States	Forsyth Medical Center - Cardiovascular Research	Winston-Salem	South Carolina
United States	Moffitt Heart & Vascular Group	Wormleysburg	Pennsylvania
United States	Metro Health Hospital	Wyoming	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
IDev Technologies, Inc.	Harvard Clinical Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Safety Endpoint: Freedom From Death, Target Lesion Revascularization (TLR), or Any Amputation of the Index Limb to 30 (±7) Days.		30 days	Yes
Primary	Primary Efficacy Endpoint: SFA Patency at 12 Months (± 30 Days), Defined as Freedom From Restenosis (PSVR = 2.0) and TLR.		12 months	Yes
Secondary	Technical (Lesion) Success	Technical (lesion) success, defined as the attainment of <50% residual stenosis by Quantitative Angiography (QA) by any percutaneous method as determined by the Angiographic core laboratory.	intraoperative	Yes
Secondary	Procedural Success	Defined as device success with < 50% residual stenosis immediately after stent placement, mean trans-stenotic pressure gradient less than 5 mmHg, and without the occurrence of death, amputation or repeat revascularization of the target lesion during the hospital stay.	intraoperative	Yes
Secondary	Device Success	Device success, defined as achievement of a final residual diameter stenosis of <50% (by QA), using the assigned treatment only.	intraoperative	Yes
Secondary	Secondary Safety Composite Endpoint	Secondary safety endpoint was a combined rate of death at 30 (± 7) days, or TLR, index limb amputation, and an increase in Rutherford-Becker Classification by 2 classes at 12 months (± 30 Days) (comparing pre- to post-procedural assessments).	12 months (± 30 Days)	Yes
Secondary	Secondary Safety Endpoint	Secondary safety endpoint was a combined rate of death at 30 (± 7) days, or TLR, index limb amputation, and an increase in Rutherford-Becker Classification by 2 classes (comparing pre- to post-procedural assessments).	24 months (± 30 Days)	Yes
Secondary	Stent Fracture Rate	Stent fractures were analyzed by X-ray evaluation by a designated core laboratory and defined as type I, II, III, IV or V.; Stent fracture classification; Type I - a single strut fracture only.; Type II - multiple single nitinol stent fractures that can occur at different sites.; Type III - multiple nitinol stent fractures resulting in complete transverse linear fracture but without stent displacement.; Type IV - a complete transverse linear type III fracture with stent displacement.; Type V - a spiral dissection of a stent.	12 months (± 30 Days)	Yes
Secondary	Stent Fracture Rate	Stent fractures were analyzed by X-ray evaluation by a designated core laboratory and defined as type I, II, III, IV or V.	24 months (± 30 Days)	Yes
Secondary	Ankle-brachial Index (ABI) Measurements on Target Limb	A ratio of the highest ankle systolic blood pressure in one leg, usually measured with a 10 cm cuff at the ankle and using a continuous wave Doppler to detect return of blood flow in the anterior tibial and posterior tibial arteries, to the highest of either arm systolic blood pressure. Performed at rest with subject in supine position.	Baseline	No
Secondary	Ankle-brachial Index (ABI) Measurements on Target Limb	A ratio of the highest ankle systolic blood pressure in one leg, usually measured with a 10 cm cuff at the ankle and using a continuous wave Doppler to detect return of blood flow in the anterior tibial and posterior tibial arteries, to the highest of either arm systolic blood pressure. Performed at rest with subject in supine position.	1 month (± 7 Days)	No
Secondary	Ankle-brachial Index (ABI) on Target Limb	A ratio of the highest ankle systolic blood pressure in one leg, usually measured with a 10 cm cuff at the ankle and using a continuous wave Doppler to detect return of blood flow in the anterior tibial and posterior tibial arteries, to the highest of either arm systolic blood pressure. Performed at rest with subject in supine position.	6 Months (± 14 Days)	No
Secondary	Ankle-brachial Index (ABI) on Target Limb	A ratio of the highest ankle systolic blood pressure in one leg, usually measured with a 10 cm cuff at the ankle and using a continuous wave Doppler to detect return of blood flow in the anterior tibial and posterior tibial arteries, to the highest of either arm systolic blood pressure. Performed at rest with subject in supine position.	12 Months (± 30 Days)	No
Secondary	Target Lesion Revascularization (TLR)	Defined as any repeat percutaneous intervention with or without evidence of stenosis = 50%, to improve blood flow inside or within 5 mm proximally and/or distally of the treated target lesion.	6 months (± 14 Days)	Yes
Secondary	Target Lesion Revascularization (TLR)	Defined as any repeat percutaneous intervention with or without evidence of stenosis = 50%, to improve blood flow inside or within 5 mm proximally and/or distally of the treated target lesion.	12 months (± 30 Days)	Yes
Secondary	Target Lesion Revascularization (TLR)	Defined as any repeat percutaneous intervention with or without evidence of stenosis = 50%, to improve blood flow inside or within 5 mm proximally and/or distally of the treated target lesion.	24 months (± 30 Days)	Yes
Secondary	SFA Patency: PSV Ratio < 2.0	Defined as freedom from restenosis [defined as diameter stenosis >50% with a peak systolic velocity (PSV) ratio = 2.0 as measured by duplex ultrasound] and TLR	6 Months (± 14 days)	No
Secondary	SFA Patency: PSV Ratio = 2.4	Defined as freedom from restenosis [defined as diameter stenosis >50% with a peak systolic velocity (PSV) ratio > 2.4 as measured by duplex ultrasound] and TLR	6 Months (± 14 days)	No
Secondary	SFA Patency: PSV Ratio = 2.4	Defined as freedom from restenosis [defined as diameter stenosis >50% with a peak systolic velocity (PSV) ratio > 2.4 as measured by duplex ultrasound] and TLR	12 Months (±30 days)	No
Secondary	Target Vessel Revascularization	Defined as any repeat percutaneous intervention or bypass surgery performed in the target vessel at 6 months post-procedure.	6 months (± 14 days)	Yes
Secondary	Target Vessel Revascularization	Defined as any repeat percutaneous intervention or bypass surgery performed in the target vessel at 12 months post-procedure.	12 months (±30 days)	Yes
Secondary	Target Vessel Revascularization	Defined as any repeat percutaneous intervention or bypass surgery performed in the target vessel at 24 months post-procedure.	24 months (±30 days)	Yes
Secondary	Limb Ischemia Improvement: Rutherford Becker Scale	Defined as an improvement in the Rutherford-Becker Clinical Improvement Scale of greater than or equal to one.; Grade +3 = Markedly improved. Symptoms are gone or markedly improved. ABI increased to >0.90.; Grade +2 = Moderately improved. Still symptomatic but with improvement in lesion category. ABI increased by 0.10 but not normalized.; Grade +1 = Minimally improved. Categorical improvement in symptoms without significant ABI increase (0.10 or less) or vice versa (but not both).; Grade 0 = No change. No categorical shift and less than 0.10 change in ABI. Grade -1 = Mildly worse. Either worsening of symptoms or decrease in ABI of 0.10.; Grade -2 = Moderate worsening. Deterioration of the subject's condition by one category or unexpected minor amputation.; Grade -3 = Marked worsening. Deterioration of the subject's condition by more than one category or major amputation.	1 month (± 7 days)	No
Secondary	Limb Ischemia Improvement: Rutherford Becker Scale	Defined as an improvement in the Rutherford-Becker Clinical Improvement Scale of greater than or equal to one.; Grade +3 = Markedly improved. Symptoms are gone or markedly improved. ABI increased to >0.90.; Grade +2 = Moderately improved. Still symptomatic but with improvement in lesion category. ABI increased by 0.10 but not normalized.; Grade +1 = Minimally improved. Categorical improvement in symptoms without significant ABI increase (0.10 or less) or vice versa (but not both).; Grade 0 = No change. No categorical shift and less than 0.10 change in ABI. Grade -1 = Mildly worse. Either worsening of symptoms or decrease in ABI of 0.10.; Grade -2 = Moderate worsening. Deterioration of the subject's condition by one category or unexpected minor amputation.; Grade -3 = Marked worsening. Deterioration of the subject's condition by more than one category or major amputation.	12 Months (±30 days)	No
Secondary	Limb Ischemia Improvement: Rutherford Becker Scale	Defined as an improvement in the Rutherford-Becker Clinical Improvement Scale of greater than or equal to one.; Grade +3 = Markedly improved. Symptoms are gone or markedly improved. ABI increased to >0.90.; Grade +2 = Moderately improved. Still symptomatic but with improvement in lesion category. ABI increased by 0.10 but not normalized.; Grade +1 = Minimally improved. Categorical improvement in symptoms without significant ABI increase (0.10 or less) or vice versa (but not both).; Grade 0 = No change. No categorical shift and less than 0.10 change in ABI. Grade -1 = Mildly worse. Either worsening of symptoms or decrease in ABI of 0.10.; Grade -2 = Moderate worsening. Deterioration of the subject's condition by one category or unexpected minor amputation.; Grade -3 = Marked worsening. Deterioration of the subject's condition by more than one category or major amputation.	24 Months (±30 days)	No
Secondary	Major Adverse Events (MAVE)	Defined as a composite rate of; stent thrombosis,; clinically apparent distal embolization (defined as causing end-organ damage, e.g. lower extremity ulceration, tissue necrosis, or gangrene),; procedure-related arterial rupture,; acute limb ischemia,; target limb amputation,; procedure related bleeding event requiring transfusion.	30 days (±7 days)	Yes
Secondary	Major Adverse Events (MAVE)	Defined as a composite rate of; stent thrombosis,; clinically apparent distal embolization (defined as causing end-organ damage, e.g. lower extremity ulceration, tissue necrosis, or gangrene),; procedure-related arterial rupture,; acute limb ischemia,; target limb amputation,; procedure related bleeding event requiring transfusion.	6 Months (±14 days)	Yes
Secondary	Major Adverse Events (MAVE)	Defined as a composite rate of; stent thrombosis,; clinically apparent distal embolization (defined as causing end-organ damage, e.g. lower extremity ulceration, tissue necrosis, or gangrene),; procedure-related arterial rupture,; acute limb ischemia,; target limb amputation,; procedure related bleeding event requiring transfusion.	12 months (±30 days)	Yes
Secondary	Major Adverse Events (MAVE)	Defined as a composite rate of; stent thrombosis,; clinically apparent distal embolization (defined as causing end-organ damage, e.g. lower extremity ulceration, tissue necrosis, or gangrene),; procedure-related arterial rupture,; acute limb ischemia,; target limb amputation,; procedure related bleeding event requiring transfusion.	24 months (±30 days)	Yes
Secondary	Index Limb Amputations	Amputation was defined as the surgical removal of tissue anywhere from the toe to hip in the ipsilateral limb of the target site.	6 months (±14 days)	Yes
Secondary	Index Limb Amputations	Amputation was defined as the surgical removal of tissue anywhere from the toe to hip in the ipsilateral limb of the target site.	12 months (±30 days)	Yes
Secondary	Index Limb Amputations	Amputation was defined as the surgical removal of tissue anywhere from the toe to hip in the ipsilateral limb of the target site.	24 months (±30 days)	Yes
Secondary	Quality of Life Assessed (QoL) by SF-12 Questionnaire	The Medical Outcomes Study 12-Item Short form survey (SF-12) was used to assess generic QoL. SF-12 Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. Physical and mental summary scores from the SF-12 are scaled to a U.S. population mean of 50 and standard deviation of 10 (higher scores are better). Multiple groups have suggested minimum clinically important changes in SF-12 summary scores to be greater than 2-2.5 points, and moderate changes to be greater than 5 points.	Baseline	No
Secondary	Quality of Life Assessed by SF-12 Questionnaire	The Medical Outcomes Study 12-Item Short form survey (SF-12) was used to assess generic QoL.SF-12 Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. Physical and mental summary scores from the SF-12 are scaled to a U.S. population mean of 50 and standard deviation of 10 (higher scores are better). Multiple groups have suggested minimum clinically important changes in SF-12 summary scores to be greater than 2-2.5 points, and moderate changes to be greater than 5 points.	6 Months (± 14 Days)	No
Secondary	Quality of Life Assessed by SF-12 Questionnaire	The Medical Outcomes Study 12-Item Short form survey (SF-12) was used to assess generic QoL.SF-12 Health Survey is validated measure using 12 questions to measure functional health and well-being from the patient's point of view. Scores on the scale are 0% (indicating poor perceived health status) to 100% (indicating excellent perceived health status) possible. Physical and mental summary scores from the SF-12 are scaled to a U.S. population mean of 50 and standard deviation of 10 (higher scores are better). Multiple groups have suggested minimum clinically important changes in SF-12 summary scores to be greater than 2-2.5 points, and moderate changes to be greater than 5 points.	12 Months (± 30 Days)	No
Secondary	Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Physical Limitation	The PAQ assesses Peripheral arterial disease (PAD)-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.	Baseline	No
Secondary	Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Physical Limitation	The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.	6 months (± 14 Days)	No
Secondary	Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Physical Limitation	The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.	12 months (± 30 Days)	No
Secondary	Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptoms	The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.	Baseline	No
Secondary	Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptoms	The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.	6 months (± 14 Days)	No
Secondary	Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptoms	The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.	12 months (± 30 Days)	No
Secondary	Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptom Stability	The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.	Baseline	No
Secondary	Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptom Stability	The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.	6 months (± 14 Days)	No
Secondary	Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Symptom Stability	The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.	12 months (± 30 Days)	No
Secondary	Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Social Limitation	The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.	Baseline	No
Secondary	Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Social Limitation	The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.	6 months (± 14 Days)	No
Secondary	Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Social Limitation	The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.	12 months (± 30 Days)	No
Secondary	Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Treatment Satisfaction	The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.	Baseline	No
Secondary	Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Treatment Satisfaction	The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.	6 months (± 14 Days)	No
Secondary	Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Treatment Satisfaction	The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.	12 months (± 30 Days)	No
Secondary	Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Quality of Life	The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.	Baseline	No
Secondary	Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Quality of Life	The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.	6 months (± 14 Days)	No
Secondary	Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Quality of Life	The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.	12 months (± 30 Days)	No
Secondary	Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Summary Score	The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.	Baseline	No
Secondary	Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Summary Score	The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.	6 months (± 14 Days)	No
Secondary	Quality of Life Assessed by Peripheral Artery Questionnaire (PAQ): Summary Score	The PAQ assesses PAD-related physical limitation, symptoms, quality of life, social function and treatment satisfaction on 0-100 scales; higher scores are better. A threshold of 8 points has been proposed as a minimum clinically important difference for the PAQ summary scale.	12 months (± 30 Days)	No
Secondary	Clinical Category: Rutherford Becker	Category and Clinical Description; 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable	Baseline	No
Secondary	Clinical Category: Rutherford Becker	Category and Clinical Description; 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable	1 Month (± 7 Days)	No
Secondary	Clinical Category: Rutherford Becker	Category and Clinical Description; 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable	12 Months (± 30 Days)	No
Secondary	Clinical Category: Rutherford Becker	Category and Clinical Description; 0 = Asymptomatic, no hemodynamically significant occlusive disease, 1 = Mild claudication, 2 = Moderate claudication, 3 = Severe claudication, 4 = Ischemic rest pain, 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable	24 Months (± 30 Days)	No
Secondary	Clinical Improvement Compared With Baseline: Rutherford Becker Scale	Clinical Improvement Compared With Baseline; Grade +3 = Markedly Improved, Grade +2 = Moderately Improved, Grade +1 = Minimally Improved, Grade 0 = No Change, Grade -1 = Mildly Worse, Grade -2 = Moderately Worsening, Grade -3 = Markedly Worsening	1 month (± 7 Days)	No
Secondary	Clinical Improvement Compared With Baseline: Rutherford Becker Scale	Clinical Improvement Compared With Baseline; Grade +3 = Markedly Improved, Grade +2 = Moderately Improved, Grade +1 = Minimally Improved, Grade 0 = No Change, Grade -1 = Mildly Worse, Grade -2 = Moderately Worsening, Grade -3 = Markedly Worsening	12 Months (± 30 Days)	No
Secondary	Clinical Improvement Compared With Baseline: Rutherford Becker Scale	Clinical Improvement Compared With Baseline; Grade +3 = Markedly Improved, Grade +2 = Moderately Improved, Grade +1 = Minimally Improved, Grade 0 = No Change, Grade -1 = Mildly Worse, Grade -2 = Moderately Worsening, Grade -3 = Markedly Worsening	24 Months (± 30 Days)	No
Secondary	Exercise Tolerance Test: Claudication Pain Distance	Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.	Baseline	No
Secondary	Exercise Tolerance Test: Claudication Pain Distance	Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.	1 month (± 7 Days)	No
Secondary	Exercise Tolerance Test: Claudication Pain Distance	Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.	12 months	No
Secondary	Exercise Tolerance Test: Claudication Pain Time (CPT)	Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.	Baseline	No
Secondary	Exercise Tolerance Test: Claudication Pain Time (CPT)	Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.	1 month (± 7 Days)	No
Secondary	Exercise Tolerance Test: Claudication Pain Time (CPT)	Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.	12 months (± 30 Days)	No
Secondary	Exercise Tolerance Test: Maximal Walking Distance	Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.	Baseline	No
Secondary	Exercise Tolerance Test: Maximal Walking Distance	Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.	1 month (± 7 Days)	No
Secondary	Exercise Tolerance Test: Maximal Walking Distance	Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.	12 months (± 30 Days)	No
Secondary	Exercise Tolerance Test: Maximal Walking Time	Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.	Baseline	No
Secondary	Exercise Tolerance Test: Maximal Walking Time	Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.	1 month (± 7 Days)	No
Secondary	Exercise Tolerance Test: Maximal Walking Time	Absolute Claudication Distance (ACD) for this study was determined by the point of termination or maximum distance walked on the treadmill due to claudication.	12 months (± 30 Days)	No